Zhen Su, Marengo Therapeutics CEO

Ipsen jumps in­to the TCR space, team­ing with start­up helmed by for­mer Mer­ck KGaA can­cer chief

Ipsen is con­tin­u­ing its deal­mak­ing ways to kick off the new month, shelling out a hand­some $45 mil­lion up­front to a TCR up­start Mon­day morn­ing.

The French phar­ma com­pa­ny is part­ner­ing with Maren­go Ther­a­peu­tics on two ex­per­i­men­tal drugs, with the biotech tak­ing on pre­clin­i­cal work and Ipsen plan­ning to run the clin­i­cal stud­ies. And the pay­off for Maren­go could be huge — Ipsen is promis­ing near­ly $1.6 bil­lion in mile­stones if both pro­grams hit all of their goals.

Mon­day’s part­ner­ship is Ipsen’s first fol­low­ing its $247 mil­lion Epizyme buy­out at the end of June and con­tin­ues a deal­mak­ing spree dat­ing back a lit­tle over a year. The com­pa­ny has en­gaged in all sorts of deals in that time, in­clud­ing with IR­LAB on a dis­ease re­lat­ed to Parkin­son’s, BAKX Ther­a­peu­tics in can­cer and Ex­i­cure for Hunt­ing­ton’s.

Ipsen al­so put down $136 mil­lion up­front last De­cem­ber to part­ner with Gen­fit in NASH, in one of its big­ger re­cent deals.

As it con­tin­ues hunt­ing its next big R&D prize, Ipsen is aim­ing to move past the $1.3 bil­lion Clemen­tia buy­out that sput­tered af­ter its main drug was hit with a fu­til­i­ty fail­ure. In or­der to fund its wheel­ing and deal­ing go­ing for­ward, Ipsen spun out its con­sumer di­vi­sion this past Feb­ru­ary for $460 mil­lion, and the Maren­go deal is the lat­est in that ef­fort.

Maren­go, mean­while, has been fo­cused on ad­vanc­ing its bis­pe­cif­ic an­ti­body plat­form tar­get­ing a spot on T cell re­cep­tors known as vari­able β chains and their vari­ants. It’s an ap­proach ex­ecs hope will help them set the com­pa­ny apart in an ever-grow­ing im­muno-on­col­o­gy space that’s now seen sev­en PD-(L)1 drugs ap­proved by the FDA.

The biotech launched last No­vem­ber with $80 mil­lion in cash and has steadi­ly marched to­ward the clin­ic with its lead pro­gram. As Maren­go CEO Zhen Su pre­vi­ous­ly told End­points News, its I/O ap­proach can be com­pared to a car: If PD-(L)1 drugs are akin to re­leas­ing the im­mune sys­tem’s brakes, then Maren­go’s ap­proach tur­bocharges the en­gine.

Maren­go hopes to file an IND for its lead can­di­date, known as STAR0602, be­fore the year is out.

TCR ther­a­pies have been all the rage in the I/O space, par­tic­u­lar­ly af­ter Im­muno­core nabbed the first-ever TCR ap­proval ear­li­er this year. And as Adap­ti­m­mune pre­pares to sub­mit its own FDA pitch, more VCs are start­ing to take a clos­er look: In April, RA Cap­i­tal, Jeito and Omega all backed a $76 mil­lion Se­ries A for a lit­tle-known Swiss biotech called CDR-Life.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

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Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Yuling Li, Innoforce CEO

In­no­force opens new man­u­fac­tur­ing site in Chi­na

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.

Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Tim Walbert, Horizon Therapeutics CEO (via YouTube)

And then there were two: Janssen bows out of Hori­zon takeover ne­go­ti­a­tions

Horizon Therapeutics announced last week that it was in talks with three pharmaceutical giants that could take over the company. You can now remove one of them from the equation.

J&J’s Janssen, after Horizon reported its initial involvement in early discussions to acquire the rare disease biotech, issued a statement Saturday that said Janssen “does not intend to make an offer for Horizon,” and that Janssen is bound by restrictions set in Rule 2.8 of the Irish Takeover Rules. These rules are in place for any company interested in taking over Irish companies, with Horizon Therapeutics currently based in Dublin.

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Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.